FDA-Drug2018-08-08Class III
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
Renaissance Lakewood, LLC
Hazard
Failed Stability Specifications: lot out of specification for elevated water vapor.
Sold states
Nationwide and Puerto Rico
Affected count
3664 bags
Manufactured in
1200 Paco Way, N/A, Lakewood, NJ, United States
Products
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1032-2018Don't want to check this manually?
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